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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS046309 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Genentech, Inc. | INDUSTRY |
| Emissary International LLC | INDUSTRY |
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The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately.
The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The procedure is to use image-based surgery (MRI or CT) to provide catheter access to ICH for the intervention, which is a one-time clot aspiration followed by instillation of rt-PA over 72 hours.
The Intraoperative stereotactic CT-guided Endoscopic Surgery (ICES) arm of the trial will determine the safety, feasibility and effectiveness of endoscopic surgery to remove ICH. This tests the first step of the MISTIE surgical procedure with an endoscope, not a rigid cannula.
We propose to test if these interventions facilitate more rapid and complete recovery of function and decreased mortality from this condition compared to conventional medical management without subjecting the patient to craniotomy. The specific objective of this trial is to test the safety of these interventions and assess their ability to remove blood clot from brain tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Management | No Intervention | Standard of care medical management as per American Heart Association (AHA) guidelines. | |
| MISTIE Surgical Management | Active Comparator | Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots. |
|
| ICES Surgical Management | Active Comparator | Intraoperative stereotactic CT-Guided Endoscopic Surgery Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIS+Cathflo Activase (drug) | Drug | MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Number 1: Rate of Mortality | Percentage of participants who died during the first 30 days after randomization. | 30 days from randomization |
| Safety Outcome Number 2: Rate of Procedure-related Mortality | Percentage of participants who died during the first 7 days after randomization. | 7 days from randomization |
| Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis | Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization. | 30 days from randomization |
| Safety Outcome Number 4: Rate of Symptomatic Rebleeding | The difference in the rate of symptomatic rebleeding 72 hours post last dose. | 72 hours post last dose |
| Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180 | Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead | 180 days from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal Modified Rankin Scale (mRS) at Day 180 | Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel F. Hanley, MD | Johns Hopkins University | Study Chair |
| Mario Zuccarello, MD | University of Cincinnati | Principal Investigator |
| Paul Vespa, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Barrow Neurosurgical Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32026447 | Derived | Hansen BM, Ullman N, Muschelli J, Norrving B, Dlugash R, Avadhani R, Awad I, Zuccarello M, Ziai WC, Hanley DF, Thompson RE, Lindgren A; MISTIE and CLEAR Investigators. Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III. Neurocrit Care. 2020 Oct;33(2):516-524. doi: 10.1007/s12028-020-00916-4. | |
| 27758940 | Derived | Vespa P, Hanley D, Betz J, Hoffer A, Engh J, Carter R, Nakaji P, Ogilvy C, Jallo J, Selman W, Bistran-Hall A, Lane K, McBee N, Saver J, Thompson RE, Martin N; ICES Investigators. ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial. Stroke. 2016 Nov;47(11):2749-2755. doi: 10.1161/STROKEAHA.116.013837. Epub 2016 Oct 6. |
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Each study center was required to demonstrate proficiency in the technical aspects of enrollment, stabilization, surgery, and drug administration. This proficiency was demonstrated on at least one pilot patient prior to randomization of the first patient in the investigational cohort of 110 randomized patients.
110 patients were randomized to the trial, and 31 were recruited as pilot patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medical Management | Standard of care medical management as per American Heart Association (AHA) guidelines. |
| FG001 | MISTIE Surgical Management | Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Intraoperative stereotactic CT-Guided Endoscopic Surgery | Procedure | Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting arm as MISTIE arm. No rt-PA administered, and in addition to best medical care. |
|
| 180 days from randomization |
| Ordinal Modified Rankin Scale (mRS) at Day 365 | Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead. | 365 days from randomization |
| Clot Size Reduction by End of Treatment | The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan. | Time from randomization until end of treatment, up to 10 days |
| Post-operative Clot Size Reduction | The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients. | Time from post-operation until end of treatment, up to 10 days |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Stanford University | Palo Alto | California | 94034 | United States |
| University of California, San Diego | San Diego | California | 92103 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Mayo Clinic | Jacksonville | Florida | 32216 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| University of Maryland Medical Systems | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University/Bayview Medical Center | Baltimore | Maryland | 21287 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| JFK Medical Center New Jersey | Edison | New Jersey | 08818 | United States |
| Mt. Sinai Medical Center | New York | New York | 10029 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Case Western University | Cleveland | Ohio | 44106 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas, Houston | Houston | Texas | 77030 | United States |
| University of Texas HSC, San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Montreal Neurological Institute at McGill University | Montreal | Quebec | H3A 2B4 | Canada |
| University of Heidelberg | Heidelberg | 69117 | Germany |
| Newcastle General Hospital | Newcastle | United Kingdom |
| 27751554 | Derived | Hanley DF, Thompson RE, Muschelli J, Rosenblum M, McBee N, Lane K, Bistran-Hall AJ, Mayo SW, Keyl P, Gandhi D, Morgan TC, Ullman N, Mould WA, Carhuapoma JR, Kase C, Ziai W, Thompson CB, Yenokyan G, Huang E, Broaddus WC, Graham RS, Aldrich EF, Dodd R, Wijman C, Caron JL, Huang J, Camarata P, Mendelow AD, Gregson B, Janis S, Vespa P, Martin N, Awad I, Zuccarello M; MISTIE Investigators. Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial. Lancet Neurol. 2016 Nov;15(12):1228-1237. doi: 10.1016/S1474-4422(16)30234-4. Epub 2016 Oct 11. |
| 26451031 | Derived | Muschelli J, Ullman NL, Sweeney EM, Eloyan A, Martin N, Vespa P, Hanley DF, Crainiceanu CM. Quantitative Intracerebral Hemorrhage Localization. Stroke. 2015 Nov;46(11):3270-3. doi: 10.1161/STROKEAHA.115.010369. Epub 2015 Oct 8. |
| 26243227 | Derived | Webb AJ, Ullman NL, Morgan TC, Muschelli J, Kornbluth J, Awad IA, Mayo S, Rosenblum M, Ziai W, Zuccarrello M, Aldrich F, John S, Harnof S, Lopez G, Broaddus WC, Wijman C, Vespa P, Bullock R, Haines SJ, Cruz-Flores S, Tuhrim S, Hill MD, Narayan R, Hanley DF; MISTIE and CLEAR Investigators. Accuracy of the ABC/2 Score for Intracerebral Hemorrhage: Systematic Review and Analysis of MISTIE, CLEAR-IVH, and CLEAR III. Stroke. 2015 Sep;46(9):2470-6. doi: 10.1161/STROKEAHA.114.007343. Epub 2015 Aug 4. |
| FG002 | ICES Surgical Management | Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The decision was made to exclude the pilot patients from the analysis...
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| ID | Title | Description |
|---|---|---|
| BG000 | Medical Management | Standard of care medical management as per American Heart Association (AHA) guidelines. |
| BG001 | MISTIE Surgical Management | Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots. |
| BG002 | ICES Surgical Management | Intraoperative stereotactic CT-Guided Endoscopic Surgery Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Outcome Number 1: Rate of Mortality | Percentage of participants who died during the first 30 days after randomization. | Posted | Number | 90% Confidence Interval | percentage of participants | 30 days from randomization |
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| Primary | Safety Outcome Number 2: Rate of Procedure-related Mortality | Percentage of participants who died during the first 7 days after randomization. | Posted | Number | 90% Confidence Interval | percentage of participants | 7 days from randomization |
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| Primary | Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis | Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization. | Posted | Number | 90% Confidence Interval | percentage of participants | 30 days from randomization |
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| Primary | Safety Outcome Number 4: Rate of Symptomatic Rebleeding | The difference in the rate of symptomatic rebleeding 72 hours post last dose. | Posted | Number | 90% Confidence Interval | percentage of participants | 72 hours post last dose |
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| Secondary | Ordinal Modified Rankin Scale (mRS) at Day 180 | Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead. | Posted | Median | Inter-Quartile Range | units on a scale | 180 days from randomization |
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| Secondary | Ordinal Modified Rankin Scale (mRS) at Day 365 | Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead. | Posted | Median | Inter-Quartile Range | units on a scale | 365 days from randomization |
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| Secondary | Clot Size Reduction by End of Treatment | The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan. | Posted | Median | Inter-Quartile Range | percentage of blood clot resolved | Time from randomization until end of treatment, up to 10 days |
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| Secondary | Post-operative Clot Size Reduction | The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients. | Analysis population only includes surgical patients. | Posted | Median | Inter-Quartile Range | percentage of blood clot resolved | Time from post-operation until end of treatment, up to 10 days |
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| Primary | Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180 | Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead | Posted | Number | 90% Confidence Interval | percentage of participants | 180 days from randomization |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medical Management | Standard of care medical management as per American Heart Association (AHA) guidelines. | 23 | 42 | 24 | 42 | ||
| EG001 | MISTIE Surgical Management | Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots. | 28 | 54 | 41 | 54 | ||
| EG002 | ICES Surgical Management | Intraoperative stereotactic CT-Guided Endoscopic Surgery Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots. | 6 | 14 | 8 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Catheter related infection | Infections and infestations | Systematic Assessment |
| ||
| Death NOS | General disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Depressed level of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Edema cerebral | Nervous system disorders | Systematic Assessment |
| ||
| Epistaxis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage: Tissue, Enlargement | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage: Tissue, New | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage: Ventricular system, New | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hypertension | Nervous system disorders | Systematic Assessment |
| ||
| Intraoperative hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ischemia cerebrovascular | Nervous system disorders | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Left renal mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| PVC's, bigemeny | Cardiac disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Anoxic brain injury | Nervous system disorders | Systematic Assessment |
| ||
| Pneumonitits | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Ventilatory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cerebrospinal fluid leakage | Nervous system disorders | Systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Intracranial hemorrhage: Catheter Tract, New | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage: Catheter Tract, Enlargement | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage: Ventricular system, Enlargement | Nervous system disorders | Systematic Assessment |
| ||
| Duodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
| ||
| Gastric hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Herniation | Nervous system disorders | Systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Sudden death NOS | General disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Ventilatory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage: Catheter Tract, Enlargement | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage: Catheter Tract, New | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage: Tissue, Enlargement | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage: Ventricular system, Enlargement | Nervous system disorders | Systematic Assessment |
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| Localized edema | General disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| HCAP | General disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound reclosure after serious fluid leak | Nervous system disorders | Systematic Assessment |
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The only disclosure restriction on the PI is that the funding agency (NIH/NINDS) can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the funding agency for review. The funding agency cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel F. Hanley | Johns Hopkins University | (410) 614-6996 | dhanley@jhmi.edu |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| United Kingdom |
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| Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of mortality than the medical arm. | Fisher Exact | One-sided test | 0.633 | Risk Difference (RD) | -2.4 | Standard Error of the Mean | 8.2 | 1-Sided | 95 | 11.2 | ICES rate=7.1, 95% upper limit=29.7; medical rate=9.5, 95% upper limit=20.5; comparison considers ICES rate minus medical rate. | No | Superiority or Other |
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| OG002 | ICES Surgical Management | Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots. |
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| OG002 | ICES Surgical Management | Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots. |
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| OG002 | ICES Surgical Management | Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots. |
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